Official announcements
Recall
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Medicines
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03/09/2014
The parallel distributor informed its supplied customers on 03.09.2014 that a counterfeit had occurred in the batch originating from Romania, which was identified by optical deviations on the stopper and the missing flip-off cap of a piercing bottle.
Safety warnings
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Blood & Tissue
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03/09/2014
The Federal Office for Public Health Safety has been informed by the Romanian authority that the first human WNV (neuro-invasive disease) infections have been recorded in Romania. The affected areas are Focşani (Vrancea county), Corabia (Olt county), and Ungheni city (Mures county).
Replacement
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Medicines
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02/09/2014
In a letter dated September 1, 2014, the marketing authorization holder informed its customers that aflatoxin contamination had been detected in follow-up tests of dry extracts of passionflower herb processed in Pascoflair, which resulted from…
messages in brief
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01/09/2014
The Federal Criminal Police Office, in cooperation with AGES, today struck a decisive blow against an international drug counterfeiting ring.
Safety warnings
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Blood & Tissue
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29/08/2014
The Federal Office for Public Health Safety has been informed by the Greek authority that the first human WNV (neuro-invasive disease) infections have been recorded in Greece.
Safety warnings
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Blood & Tissue
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21/08/2014
The Federal Office for Safety in Health Care was informed by the Vienna Blood Transfusion Service (ÖRK) that a suspected WNV infection had been recorded in Austria.
Recall
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Medicines
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19/08/2014
The parallel distributor informed its supplied customers on 13.08.2014 and asked for a stock check of the affected batches, as these batches were illegally distributed from Italy and entered the legal distribution chain.
Recall
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Medicines
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07/08/2014
The manufacturer informed its supplied customers by letter dated July 24, 2014, that the active ingredient manufacturer "SIMS Società Italiana Medicinali Scandicci srl" was assessed by the responsible inspection authority as not GMP-compliant and…
messages in brief
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28/07/2014
Reassessment completed with regard to higher body weight or BMI.
Recall
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Medicines
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17/07/2014
The marketing authorization holder informed its supplied customers by letter dated July 15, 2014, that a loss of sterility for the Absorbable Collagen Sponge (ACS) was detected during a stability study after 24 months, so that a recall is being…